Cleocin T

Treats acne vulgaris. NDA 50600, held by Pfizer. Clindamycin Phosphate.

As of Nov 13, 2026, NDA 50600 (Cleocin T), held by Pfizer, was first approved by FDA on May 31, 1989, with 12 approved supplements and 0 published complete response letters.

First approved: May 31, 1989
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE CLEOCIN T Topical Solution, CLEOCIN T Topical Gel and CLEOCIN T Topical Lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS ).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
May 31, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Cleocin TEQ 1% BASE · lotion;topical	Clindamycin Phosphate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 12, 2025	Supplement 20Labeling · Standard review	Approved	Label Letter
Dec 16, 2019	Supplement 18Labeling · Standard review	Approved	Letter Label
Apr 19, 2019	Supplement 17Labeling · Standard review	Approved	Label Letter
Nov 16, 2017	Supplement 16Labeling · Standard review	Approved	Label Letter
Jan 15, 2016	Supplement 14Labeling · Standard review	Approved	Label Letter
Apr 4, 2014	Supplement 13Labeling · Standard review	Approved	Label Letter
May 30, 2003	Supplement 7Labeling · Standard review	Approved	Letter Label
Jul 14, 2002	Supplement 2Labeling	Approved	Label Letter
Sep 5, 1994	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 20, 1993	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 7, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 23, 1991	Supplement 3Manufacturing · Standard review	Approved	None posted
May 31, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50600
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters